I’m happy to report that it has been months since I heard someone say in a meeting: “We’re waiting to see the FDA’s guidance on social media before we get involved.”
Sometime in 2011, we all seemed to collectively realize: It’s just not going to be that easy. Instead, pharma would have to find its own way. To date, at least 60 pharma brands have done just that. They’ve built internal guidelines, tested approaches, and actively gotten involved in social media. Still, who doesn’t want to know what the FDA might have in store next? Here’s what we expect:
Continuing Stream of Guidance
Right around the time we had given up hope of those long-ago social media hearings actually resulting in any specific guidance, the FDA quietly released draft guidance on unsolicited requests for off-label information. Although reception of the new guidance was mixed, one thing was clear – the FDA has become incredibly savvy about the role digital plays in helping consumers make healthcare choices.
Inside the guidance, the FDA comments not only on that critical role digital plays, but also why it’s important that the industry be allowed to engage:
“…because firms usually have robust and current information about their products, it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are made in public forums, especially since other responders may not provide or have access to the most accurate and up-to-date medical product information.…”
You can read the critical takeaways from this new document on MedAdNews.
When this new guidance came out at the very end of last year, the FDA noted that it was the first of a series of planned releases. We can expect to see up to 12 similarly focused draft documents over the next two years. Personal bet: clinical trial recruitment will be one of them.
One thing that’s unlikely to ever happen: straight social media guidance. For the FDA, it’s about the message, not the medium. They’ve created guidelines for promotion and advertising (fair balance, truthful, adequate disclosure of risk, etc). They expect us to figure out how to apply them on Twitter.
Learn-worthy Advice from App Regulation
Last summer, the FDA proposed an oversight approach to apps – actually, a very specific category of apps: those that are an accessory to a medical device or transform a mobile communication’s device into a regulated medical device by using attachments, sensors or other devices.
The critical component there is that the guidance is around the role the tools play (the action/interaction), not the medium they use. Some of these “channels” (or platforms, or destinations…pick your word) shift the interface of healthcare (where people get it, how they use it, etc). That‘s where the FDA wants to focus.
We expect future rounds of proposed guidance to be focused on a critical action or interaction (not a medium). That said, the FDA has social/digital awareness (in a big way). So, each approach will likely offer specific POVs on what to do on open platforms versus closed communication. By open platforms, we mean both social destinations and websites/apps/digital tools with social elements – like rating, commenting, or connecting. By closed, we mean more traditional 1:1 and 1:many communication.
Potentially Game-changing Inquiries into Bigger Issues
The biggest thing to happen to healthcare and social media might have nothing to do with advertising and promotion.
This March, the FDA held hearings about using innovative technologies to expand the number of medications that can be administered over the counter. That’s right: prescribing by self-screening. The reason is simple: The system is over burdened. Writing about the hearings in the Federal Register, the agency said:
“Eliminating or reducing the number of routine visits could free up prescribers to spend time with more seriously ill patients, reduce the burdens on the already overburdened health care system, and reduce health care costs.”
The testimony focused on drugs commonly prescribed for high cholesterol, high blood pressure, migraine headaches, and asthma. The agency also may explore easier access to diabetes treatments.
Now, we’re not just talking about the (paranoid?) self-diagnosis you might be doing with Dr. Google or on WebMD late at night. This is a broader category of true self-screening:
- Kiosks at pharmacies
- Meters and trackers
But it does take away one of the critical conversations we plan for: Doctor to Patient.
When the tools and the crowd become the expert, social communities and open platforms become more important. Cracking that new point of influence will put social media back in the spotlight.
What do you think we can expect next from the FDA on social media?